FDA.reportPublic FDA data

NDC 68071-3588-01 - Dexamethasone

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
68071-3588
Requested NDC
68071-3588-01
Package NDCs from labels
68071-3588-6, 68071-3588-1, 68071-3588-8, 68071-3588-01
Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2025-07-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Dexamethasone Tablets, USP Rx onlyNuCare Pharmaceuticals,Inc.2025-07-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3588-1Dexamethasone10 in 1 BOTTLETABLET103
68071-3588-6Dexamethasone6 in 1 BOTTLETABLET63
68071-3588-8Dexamethasone8 in 1 BOTTLETABLET83

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3588DEXAMETHASONE TABLET [NUCARE PHARMACEUTICALS,INC.]2Current NDC, 3 package rows20241204_141e16a7-1f3d-3943-e063-6294a90ac5a9.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 6 of 8 · 158 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ciprofloxacin and DexamethasoneCIPROFLOXACIN AND DEXAMETHASONENorthStar RxLLC130deaf4-ced5-abcb-2a01-205c640ddf962024-11-01Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Neomycin and Polymyxin B Sulfates and DexamethasoneNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONESandoz Inc7f2e3c46-9f39-45e7-99a9-64cc4f6f649d2024-10-31Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
TOBRAMYCIN AND DEXAMETHASONETOBRAMYCIN AND DEXAMETHASONEA-S Medication Solutions8d6a8a22-fd97-43e7-a89c-b1f32710a7732024-10-14Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEBryant Ranch Prepacke652b041-2a0b-4bcd-a420-5d026302edbb2024-09-23Warnings, Adverse reactionsExact identifier
rxcui: 197582
unii: 7S5I7G3JQL
Neomycin Polymyxin B Sulfates and DexamethasoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONEBausch & Lomb Incorporatedd6d78668-a978-4cd3-bbcd-1293b5044ec92024-09-15Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEDirect_rx214dea63-d77a-922a-e063-6294a90a967e2024-09-04Warnings, Adverse reactionsExact identifier
rxcui: 197580
unii: 7S5I7G3JQL
Tobramycin and DexamethasoneTOBRAMYCIN AND DEXAMETHASONEA-S Medication Solutions11c2ba9a-7aa3-4f78-aa2f-2a35d26716812024-08-12Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Neomycin and Polymyxin B Sulfates and DexamethasoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONENuCare Pharmaceuticals,Inc.54da7bef-c3b0-4353-e054-00144ff8d46c2024-07-10Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEProficient Rx LP45fd8030-dbe3-4da4-9d0a-6549cf4f73592024-07-01Warnings, Adverse reactionsExact identifier
rxcui: 197580
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEBryant Ranch Prepack710ce0fc-78b3-402d-a2ca-e5eda09f32112024-06-11Warnings, Adverse reactionsExact identifier
application number: ANDA215604
rxcui: 343033
unii: 7S5I7G3JQL
Neomycin and Polymyxin B Sulfates and DexamethasoneNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONEA-S Medication Solutions6791e6c3-514d-4b98-8887-ca2b894576b52024-06-10Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Neomycin Polymyxin B Sulfates and DexamethasoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONENuCare Pharmaceuticals,Inc.691bc5ca-5d61-60c2-e053-2991aa0abb932024-06-07Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Tobramycin and DexamethasoneTOBRAMYCIN AND DEXAMETHASONENuCare Pharmaceuticals,Inc.61693e79-81d1-3162-e053-2a91aa0ae9252024-06-06Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Ciprofloxacin and DexamethasoneCIPROFLOXACIN AND DEXAMETHASONEDr. Reddy's Laboratories, Inc.f07cf7d6-c233-884e-342d-c6c8cd2c84382024-05-30Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEBryant Ranch Prepackc75360d3-2e4f-4620-a8f0-db28b1aa704b2024-05-28Warnings, Adverse reactionsExact identifier
application number: ANDA215604
rxcui: 197582
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEZydus Lifesciences Limitede9012a11-6219-4272-aea2-b7328bbcf5232024-05-13Exact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEViona Pharmaceuticals Inc360d3af0-8f69-4e82-ab5f-1f70cc2025d42024-05-13Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONENuCare Pharmaceuticals,Inc.17f56402-331e-2e3d-e063-6394a90acc0e2024-05-08Warnings, Adverse reactionsExact identifier
application number: ANDA215604
rxcui: 197582
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEBryant Ranch Prepack36f104ba-80b4-4713-aa74-f80483b7bded2024-04-03Warnings, Adverse reactionsExact identifier
rxcui: 197582
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEViona Pharmaceuticals Inc93bb34a7-c8ca-4dab-b2a0-cbe011e1090c2024-03-30Warnings, Adverse reactionsExact identifier
rxcui: 343033
rxcui: 197577
rxcui: 197582
rxcui: 197580
rxcui: 197583
unii: 7S5I7G3JQL

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.